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Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

NCT04777851 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-09

No results posted yet for this study

Summary

REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) for the first-line treatment of hepatocellular carcinoma (HCC or liver cancer). Approximately 496 patients in around 80 clinical sites worldwide will be randomized to receive either:

* Investigational arm: Regorafenib in combination with pembrolizumab
* Control arm: Transarterial chemoembolization (TACE) or transarterial radioembolization (TARE)

In both arms, patients will receive trial treatment until progressive disease, unacceptable toxicity, deterioration of patient's condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria is met. After trial treatment discontinuation, subsequent treatment will be administered according to the Investigator's clinical judgment.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Regorafenib in combination with pembrolizumab

Randomized patients will receive regorafenib at a dose of 90 mg per day by mouth on days 1 to 21 of a 28-day cycle, in combination with pembrolizumab 400 mg using a 30-minute intravenous infusion, on day 1 (D1) of a 6-week cycle.

PROCEDURE

Loco-regional therapy

Patients will be treated with TACE or TARE "on-demand" according to site's standard of practice.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Translational Research in Oncology

    lead OTHER

Principal Investigators

  • Peter R Galle, MD · University Medical Center, Mainz, Germany

  • Richard S Finn, MD · UCLA Department of Medicine, Division of Hematology-Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2026-02-26
Completion
2026-02-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Georgia
  • Germany
  • Hong Kong
  • Italy
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777851 on ClinicalTrials.gov